Cadonilimab with chemotherapy followed by concurrent chemoradiotherapy for locally advanced cervical cancer

A Phase III, Multicenter, Open-label, Randomized Controlled Clinical Study on the Treatment of Locally Advanced Cervical Cancer With Cadonilimab Combined With Chemotherapy Followed by Concurrent Chemoradiotherapy

This phase 3 study will test whether adding cadonilimab to initial chemotherapy and then giving standard concurrent chemoradiotherapy helps women aged 18–70 with stage IIB–IVA locally advanced cervical cancer have better tumor responses and outcomes than standard chemoradiotherapy alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 378 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Cadonilimab
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07400536 on ClinicalTrials.gov

What this trial studies

This randomized phase 3 trial compares an induction and concurrent immunotherapy strategy — cadonilimab combined with chemotherapy followed by standard external-beam radiotherapy plus brachytherapy and concurrent chemotherapy — against the current standard of concurrent chemoradiotherapy alone. Eligible patients are adults with histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer at FIGO stage IIB–IVA and at least one measurable lesion by RECIST v1.1. The study tracks efficacy endpoints (tumor response, progression-free and overall survival) and safety outcomes throughout treatment and follow-up. Treatments are delivered at a single lead center with standardized radiotherapy and chemotherapy protocols.

Who should consider this trial

Good fit: Ideal candidates are women aged 18–70 with histologically confirmed squamous, adenocarcinoma, or adenosquamous cervical cancer at FIGO stage IIB–IVA, ECOG performance status 0–1, at least one measurable lesion, and adequate organ function who have not received prior antineoplastic therapy.

Not a fit: Patients with distant metastatic disease (FIGO stage IVB), prior total hysterectomy, inability to undergo brachytherapy, or those outside the age/ECOG/organ-function requirements are unlikely to benefit from enrollment.

Why it matters

Potential benefit: If successful, the regimen could increase tumor response and prolong progression-free and overall survival for patients with locally advanced cervical cancer.

How similar studies have performed: Early-phase studies of cadonilimab and clinical experience with other PD-1/PD-L1 agents in cervical cancer have shown activity, but robust phase 3 evidence specifically for cadonilimab in this setting is still limited.

Eligibility criteria

Inclusion Criteria:

To be enrolled, subjects had to meet all of the following criteria:

1. Female, aged 18-70 years (inclusive of cutoff values);
2. Histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix;
3. Patients with stage IIB-IVA cervical cancer (FIGO stage 2018) who had not received any previous antineoplastic therapy;
4. At least one measurable lesion according to RECIST v1.1;
5. Eastern Cooperative Oncology Group (ECOG) performance-status score 0-1;
6. Have adequate organ function.

Exclusion Criteria:

Subjects were excluded from the study if they met any of the following criteria:

1. Distant metastatic disease (including inguinal lymph node metastasis and lymph node metastasis above the level of the superior edge of the L1 pyramid in the proximal cephalic region, according to FIGO 2018 stage IVB);
2. He had undergone total hysterectomy (removal of the corpus uteri and cervix);
3. Inability to undergo brachytherapy or refusal to undergo brachytherapy for reasons such as anatomical abnormalities;
4. Had received any previous antineoplastic therapy, including but not limited to surgery (except biopsy), radiotherapy, or systemic therapy (chemotherapy, immunotherapy, targeted therapy);
5. Had any condition that was deemed by other investigators to be ineligible for participation in the trial.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Principal investigator: Guiling Li, PHD — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: Ting Liu, MD

Conditions Locally Advanced Cervical Carcinoma